NCT04195204

Brief Summary

The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Nov 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

January 5, 2022

Status Verified

January 1, 2022

Enrollment Period

2.2 years

First QC Date

November 27, 2019

Last Update Submit

January 4, 2022

Conditions

Postoperative Cognitive DysfunctionPostoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • The feasibility of tropisetron intervention on POCD in patients after cardiac surgery

    The feasibility will mainly be determined by the percentage of participants who completed the whole study procedure from recruitment to the 1-month follow-up.

    Within 30 days after surgery

Secondary Outcomes (11)

  • Incidence of postoperative cognitive dysfunction

    One day before surgery, discharge from hospital and 1 month after surgery

  • Incidence of postoperative delirium

    Within 7 days after surgery

  • Functional status measurement

    One day before surgery and 1 month after surgery

  • EEG frequency spectrum

    Within 3 days after surgery

  • Postoperative Pain

    Within 7 days after surgery

  • +6 more secondary outcomes

Other Outcomes (1)

  • Incidence of major adverse cardiac and cerebral events

    Within 30 days after surgery

Study Arms (2)

Tropisetron

EXPERIMENTAL

Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery.

Drug: Tropisetron

Placebo

PLACEBO COMPARATOR

Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery.

Drug: Placebos

Interventions

TropisetronDRUG

Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.

Tropisetron
PlacebosDRUG

Investigators administrated intravenously saline solution as a placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written consent given
  • Scheduled to undergo elective coronary artery bypass graft surgery under general anesthesia
  • ASA Physical Score I-IV

You may not qualify if:

  • Inability to give informed consent.
  • Contraindications to tropisetron.
  • Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.
  • History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
  • History of antipsychotic drug use.
  • Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Chaoyang Hospital, Capital Medical University

Beijing, 100020, China

RECRUITING

MeSH Terms

Conditions

Postoperative Cognitive ComplicationsEmergence Delirium

Interventions

Tropisetron

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsCognitive DysfunctionCognition DisordersNeurocognitive DisordersMental DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

November 27, 2019

First Posted

December 11, 2019

Study Start

November 1, 2020

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

January 5, 2022

Record last verified: 2022-01

Locations

CN(1)